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KemPharm Taking Ritalin Prodrug Into Phase III For ADHD

 
• By Joseph Haas

Months after reaching agreement with FDA to refile the NDA for its abuse-deterrent opioid Apadaz, KemPharm has gotten the okay to take its prodrug of Ritalin into Phase III for ADHD.

Roughly a year after entering a dispute resolution process with US FDA to refile the NDA for its abuse-deterrent opioid candidate and ultimately prevailing, KemPharm Inc. has obtained the agency’s okay to take its second prodrug candidate, a methylphenidate formulation for attention deficit/hyperactivity disorder, into Phase III.

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• By Eliza Slawther

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Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

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